Plain English Summary

Background and study aimsMaternal and perinatal mortality (death of mother/newborn baby) are major problems for which progress in sub-Saharan Africa has been inadequate, although childbirth services are available even in the poorest countries. Reducing these deaths is the aim of two of the main Millennium Development Goals. There have been many initiatives to remedy this situation, such as the Advances in Labour and Risk Management (ALARM) International Program, whose purpose is to improve the quality of obstetric services in low-income countries. However, few interventions have been tested in this context with rigorous methods for analysing effectiveness in terms of health outcomes. The aim of this study is to assess the effectiveness of the ALARM International Program (AIP) at reducing maternal mortality in referral hospitals in Senegal and Mali.

Who can participate? Pregnant women from 12 to 45 years old who deliver in one of the participating hospitals

What does the study involve?Participating hospitals are randomly allocated to the intervention group or the control group. The intervention group hospitals receive a combination of two approaches aimed at improving the performance of health personnel: educational outreach visits and the introduction of facility-based maternal death reviews. The intervention lasts 2 years. The control group hospitals do not receive the intervention. Maternal mortality rates, resource availability, quality of care, maternal morbidity (illness), perinatal mortality, and health personnel satisfaction are compared between the two groups.

What are the possible benefits and risks of participating? Not provided at time of registration

Where is the study run from?Université de Montréal (Canada)

When is the study starting and how long is it expected to run for? March 2007 to November 2011

Who is funding the study?Canadian Institutes of Health Research (CIHR) (Canada)

Acronym

Study hypothesis

Principal hypothesis:The program ALARM international reduces by 30% the global case fatality rate, measured in the hospitals during the post-intervention period, compared to the control group.

Secondary hypotheses: 1. Reduction of stillbirth and early neonatal mortality 2. Improvement in the quality of care by a better utilisation of local resources and changes in professional practices 3. Increase in health workers satisfaction

Study design

Primary study design

Secondary study design

Trial setting

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Maternal mortality/neonatal mortality

Intervention

Training of opinion leaders to optimal professional practices and to maternal deaths audits (training of trainers):1. Training of obstetric team in hospital 2. Implementation of audit in hospitals3. External facilitators visits 4. Recertification of opinion of the leaders

Overall trial start date

01/03/2007

Overall trial end date

01/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

At the hospital level: 1. Public referral hospital (district, department, regional or national)2. Availability of surgical theatre3. Annual number of deliveries greater than 8004. Consent form signed by the maternity director and hospital director to participate in the study

At the individual level:1. Women admitted for delivery including those referred to the hospital or who died in the transport to hospital 2. Pregnant women from 12 to 45 years old

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

174 688 women nested in 44 hospitals

Participant exclusion criteria

At the hospital level:1. Private hospital2. Public hospital with less than 800 deliveries per year3. Surgical theatre not operational4. Hospitals where the maternal deaths audit were already implemented5. No signed consent form directors of maternity and hospital

At the individual level: 1. Women admitted not pregnant2. Women admitted for complications during the first quarter of pregnancy (miscarriage, ectopic pregnancy)3. Women admitted after 42 days after the end of pregnancy4. Late maternal deaths or deaths from accidental causes